T1D Exchange 2017 Annual Meeting

October 3, 2017; Boston, MA; Full Report – Draft

Executive Highlights

Greetings from Boston! Our team touched down just in time for the T1D Exchange’s 5th annual meeting, which left us feeling hopeful for the future of type 1 diabetes care.  The packed agenda included updates on CGM metrics and outcomes beyond A1c from Dr. Roy Beck, a patient panel on the psychology of aging with type 1 diabetes, and remarks on how to forge greater patient centricity in the US healthcare system. Read on for detailed summaries of the most notable sessions from this always-enjoyable meeting.


Detailed Discussion and Commentary

The T1D Exchange Clinic Registry – Recent Highlights, Data & Insights

Roy Beck, MD (Jaeb Center for Health Research, Tampa, FL)

Dr. Roy Beck gave a master class on CGM: where we’ve been, where we are, and where we’re going. Titled “CGM: Why is Use Not Universal,” Dr. Beck highlighted that CGM use is increasing quite rapidly in the Exchange, but still isn’t as high as it should be. The two most important slides of the talk, pasted below, showed very encouraging uptake in our view: CGM use in the T1D Exchange has risen from 7% in 2010-2012 to 24% in 2016-2017. Moreover, CGM penetration is now an impressive 58% in pumpers under 6 years old in the Exchange, and 40%+ in patients ages 26-64 years. While these numbers should be 100% in every group – and clearly overestimate real penetration across the US population – we think they are good sign for the field. Notably, 77% of CGM users in the T1D exchange use Dexcom vs. only 23% for Medtronic - a massive change from 2010-2012, when it was 45% Dexcom, 53% Medtronic, and 2% Abbott. It was also striking to see that as of March 2017, 42% of Medtronic pumpers in the T1D Exchange use Dexcom CGM, far more than we would have guessed and indicating Medtronic has a lot of CGM catch-up to play - even in its own pump population. We’ll be fascinated to see how this mix changes once FreeStyle Libre launches in the US this fall and as Medtronic commercializes its own Guardian Connect standalone CGM (still under FDA review). Dr. Beck covered some of the well-known hassles with early CGMs (GlucoWatch, Dexcom SEVEN, Medtronic Guardian), as well as continued issues with cost – e.g., a June 2016 Glu question of the day found that, among those who gave up using CGM, 30% did so due to cost, and 25% due to accuracy. (We think these problems will continue to be solved with next-generation devices.) Dr. Beck then covered several recent positive studies, which should bode well for uptake and market expansion. Dexcom’s DIaMonD study in MDIs (type 1 data published in JAMA; type 2 data published in Annals of Internal Medicine) found reduced A1c and improved time-in-range with CGM, and also very high CGM Satisfaction Scale scores – far improved over the earlier devices used in the JDRF CGM study (Dexcom G4 with software 505 vs DexCom Seven, MiniMed Paradigm REAL-Time Revel CGM, and the FreeStyle Navigator). Even with no visits or contacts between three and six months, Dr. Beck noted, the vast majority of DiaMonD patients (>90%) kept using CGM seven days a week, even among those >60 years old and those with baseline A1c >9% (we are hardly surprised by people over 60!). Dr. Beck also pointed out strong outcomes and wear time for Dexcom CGM in the GOLD study of MDIs (also published in JAMA), as well as positive glycemic and wear-time data in the REPLACE and IMPACT trials with Abbott’s Freestyle Libre. He concluded his presentation by explaining why the data CGM provides is so useful – more details below!

  • Drs. Beck and Rich Bergenstal recently published a much buzzed-about paper in Diabetes Care, “The Fallacy of Average: How Using HbA1c Alone to Assess Glycemic Control Can Be Misleading.” As we’ve covered previously, Dr. Beck noted that the same A1c value can represent vastly different average blood glucose values – an A1c of 8.0% can be measured from an average blood glucose of anywhere from 155 to 218 mg/dl. In his words, “If you’re using A1c alone, you just really don’t know what the patient’s glycemic control could be.” Patients with high A1c’s can still be experiencing frequent hypoglycemia, and HCPs are left in the dark without CGM.
  • Dr. Beck presented an interesting post-hoc analysis of the ACCORD trial, reiterating an argument we’ve heard from Dr. Rich Bergenstal before: the increased mortality in ACCORD only occurred in patients who had an A1c higher than their mean glucose would have indicated. (At AADE 2011, Dr. Bergenstal presented this SMBG data from ACCORD and called the phenomenon “Divergence from Glycemic Target.”) It’s possible that intensive therapy was driving patients into hypoglycemia, as treatment decisions were likely based on an erroneously high A1c value; these patients did, in fact, experience more severe hypoglycemia. Dr. Beck finds this explanation compelling, as do we. Of course, fingerstick data cannot completely answer the question, which is why we hope future trials will universally use CGM to answer questions like this. This could also imply the ACCORD trial should not have been stopped.
  • Despite perception that CGM data isn’t as accurate as fingerstick BGM, the newest CGMs are at least as accurate as fingersticks and have become more accurate over time. Dr. Beck noted that MARD for Dexcom G5 is 9.0%, compared to 10.6% for Medtronic’s Guardian Sensor 3 and 9.7% for the just-approved Freestyle Libre with a 10-day sensor and 12 hour warmup in the US version (though we doubt “real world” is just like RCTs, the accuracy is still likely better). And more improvements to CGM are coming down the pipeline: Dexcom’s G6 is expected to have a similar or possibly lower MARD to G5, but with only one calibration per day, a 10-day sensor, no problem with using acetaminophen, better accuracy on day one, and a more patient-friendly autoinserter and smaller wearable. (We saw pre-pivotal G6 data at DTM 2016, but the pivotal results have not been shared publicly. An FDA submission was expected last month, and we’ll hear more on Dexcom’s 3Q17 call.) Freestyle Libre is of course factory-calibrated, so no fingersticks are required; Dr. Beck pointed out that patients do have to scan data by swiping the reader over the sensor. Senseonics Eversense, available only in Europe and currently under FDA review, has a 90-180 day implantable sensor with a transmitter worn on the skin above and a MARD of 8.8%. Obviously, the field is maturing and will only continue to do so, advances that we think will expand adoption. Cost, however, will continue to be a challenge for uptake and we’ll be interested to watch how FreeStyle Libre’s US launch proceeds in pharmacies by end of year.
  • Dr. Beck reminded attendees that traditional blood glucose monitors aren’t as accurate as many believe. In an MGH study of 17 meters, MARD ranged from 5.6%-20.8%, and nine of the meters tested had an MARD over 10%. In the Diabetes Technology Society’s surveillance study of 18 meters (see our July coverage), only six BGMs passed all three substudies, five passed two, three passed one, and four meters failed all three. As we pointed out in July, we were struck to see that ~68% of the Medicare mail order BGM market in 2016 was for meters that didn’t pass the accuracy bar in DTS’ evaluation. This is yet another reminder why getting to factory calibration is critical – it should improve both actual and perceived accuracy of CGMs.

Questions and Answers

Q: Is there any move to get people to measure mean glucose instead of A1c? No one understands area under the curve, so would mean glucose be better? Second, is CGM use correlated to income levels, education, or diabetes centers?

A: If I had to choose one thing to have been A1c and CGM measured mean glucose, it would be mean glucose.  However, A1c is the only measure that has been shown to correlate with long term complications. I think the correlation is with glycemic control, but some think it’s an independent effect. FDA doesn’t like “estimated A1c” and thinks it’ll confuse patients; we’re coming up with some other term for it that we want to have on reports given to patients. Understanding the discrepancy itself would be useful.

At least in our T1D Exchange registry data, CGM use is economically related. However, we published one paper on racial disparities looking at cultural issues. In African Americans with income over $100,000, their use of pumps was still substantially lower than whites when matched for income. Patients or providers or some combination of those is creating bias, but this needs more work to understand better.

Aging with Type 1 Diabetes

Dana Ball (T1D Exchange, Boston, MA); Nick Argento, MD (Howard County General Hospital, Columbia, MD); Bunny Kasper (JDRF, Hamden, CT); Sandy Brooks, RN (Boston, MA); Paul Madden (ADA, Boston, MA)

The meeting kicked-off with an emotional panel discussion on the complexities of aging with diabetes. Traditionally, this has been an under-considered aspect of the disease, but is increasingly important now that living long with type 1 diabetes is the norm rather than the exception. Moderated by T1D Exchange’s Mr. Dana Ball, the panel included four people living with type 1 diabetes with very different stories: Mr. Paul Madden, 65, who has 55 years of experience with diabetes and a 45-year career in diabetes-related global health; Ms. Bunny Kasper, 74, who suffered decades of misdiagnosis after developing diabetes in her 20s during pregnancy; Ms. Sandy Brooks, a “surgical type 1” who developed diabetes five years ago after a pancreatectomy for chronic pancreatitis; and Dr. Nick Argento, 57, who has experienced type 1 diabetes “at both ends of the stethoscope,” as both a patient and an endocrinologist. The conversation delved into how the normal challenges of aging – medical issues, isolation, loneliness, and vulnerability – are magnified by diabetes. One audience member astutely defined the diabetes/aging process as a collection of “new complications” beyond the traditional CV, renal, retinal, and neural comorbidities that come to mind. Indeed, this is a new therapeutic topic to consider with increased life expectancy for people with type 1 diabetes. It’s good news overall that advances in care lead us to think about aging, and the diabetes field is now presented with sometimes controversial questions about A1c goal-setting and other therapeutic choices for elderly patients. We hope these decisions are made with the patient experience in mind – as Ms. Kasper articulated, being a senior with type 1 diabetes can feel isolating, as few have an in-depth understanding of the needs of this patient population. Below, we include some of the most striking Quotable Quotes from this discussion.

  • How would you describe aging with diabetes in two words?
    • “First, determination. Damn it, you don’t get through it unless you’re determined. My second word is blessed – blessed with a village to help you. Thank goodness when I was diagnosed I had a humble PCP who didn’t want to tackle my diabetes and sent me to a specialist.” – Mr. Paul Madden
    • “My first word is brave, which is the word my toddler grandson used when he was first diagnosed with type 1 diabetes. My second word is isolated. Especially as a senior, people really don’t understand our needs.”  – Ms. Bunny Kasper
    • “My words are resilient and optimistic. Until I got the diabetes diagnosis, I didn’t know what I was capable of dealing with. I face the challenges every day and try to put a positive spin on it, and without this I wouldn’t be able to get through the day.” – Ms. Sandy Brooks
    • If I were diagnosed 10 years earlier, I wouldn’t be here – or I’d be here but blind and on dialysis. I’m also blessed to be born in the US where we have access to the most advanced technology. At my age, if I’d been born in India, I’d have died at age 9.” – Dr. Nick Argento
  • What is your biggest concern about aging with type 1 diabetes?
    • “Who will take care of me if I can’t take care of myself? My mother had Alzheimer’s disease – what if I get it, too? Who will give me my insulin? Who’s going to care? God help me if I have to be hospitalized. And this isn’t a question way in the back of our minds – it’s right there. Being isolated is a scary issue, and being vulnerable is terrifying.”– Ms. Bunny Kasper
    • “What if I need long-term care? Type 1 diabetes isn’t something you learn in nursing school. I’ve been hospitalized before for other reasons and I’ve luckily been able to take care of my diabetes, but what if someday I’m not?” – Ms. Sandy Brooks
    • “I’m scared of my network breaking down. For many of my patients, their spouse was their primary advocate, but then has a stroke, gets dementia, or dies. I’m particularly fearful of institutions. They are dangerous places for people with type 1 diabetes. I know enough to advocate for myself, but I’m deathly afraid of getting into a car accident or some situation where I’m not. It creates tremendous anxiety.” – Dr. Nick Argento
    • “To be alone and not be supported with my care. Even with loving and well-meaning people around, they may not know how to support me with my diabetes.” – Mr. Paul Madden
  • What are the barriers to addressing the issue of aging with type 1 diabetes?
    • “We don’t discuss it because we are afraid of getting old. We live in a disposable society obsessed with youth – if it’s old, throw it away.” – Ms. Sandy Brooks
    • There’s a belief that because we’ve been doing it for years we have it ‘down.’ But there’s very little understanding that we’re tired and this can be a lot to deal with.” – Ms. Bunny Kasper
    • The Joslin medalists used to be an outlier group, but now it’s the norm and not the exception to survive 50 years with diabetes. There is an explosion in the number of type 1 individuals who are older now, and though this is a success story, it’s also a challenge. No one likes to talk about how they will deal with all the other normal limitations of aging, like arthritis and declining mental status, and how this is made even more challenging with diabetes.” – Dr. Nick Argento
    • “We don’t do well with chronicity. Chronic diseases force us to adapt to a new norm that’s not as healthy as it was before diabetes.” – Mr. Paul Madden

Keynote Address

Greg Simon (Biden Cancer Initiative, Washington, DC)

Mr. Greg Simon, Director of the Biden Cancer Initiative, held the audience spellbound in an inspiring keynote calling for a fundamental shift toward patient centricity in the US healthcare system. With an illustrious resume as chief policy advisor to Vice President Al Gore on everything from the Human Genome Project to the International Space Station, the founding president of the Milken Institute’s FasterCures division, former Senior Vice President at Pfizer, CEO of the healthcare investing firm Poliwogg, and now Director of the Biden Cancer Initiative (a non-profit spinoff from the Obama administration’s White House Cancer Task Force), Mr. Simon is a master strategist boasting deep expertise in finance, biotechnology, and healthcare policy. He articulated an overarching goal of “bringing the healthcare system up to speed, arguing provocatively that healthcare has failed to modernize at the pace of other major industries. Mr. Simon questioned why major scientific findings are unveiled at annual conferences rather than in real time, and why there isn’t greater interoperability for medical records. (Hear, hear!) Against the backdrop of ongoing debates on Capitol Hill over the fate of the Affordable Care Act (ACA) and whether healthcare should be a right or a privilege, Mr. Simon pointed out that, for better or worse, healthcare in the US is treated like a business. Pointing to the complex interplay between PBMs, manufacturers, and insurance companies, he characterized our current healthcare system a poorly-run business at that, challenging the audience to consider how we could reframe things so that health is treated as an investment or asset rather than a cost. According to Mr. Simon, inefficiencies in our current system are a product of misalignment in the cultures surrounding science, technology, and money. At the crux of this, he argued, is a disconnect between the goals of modern research (to fully “understand” the pathophysiology of a disease) and the goals of philanthropy (to make diseases easier for the people living with them).

  • “The missing element in our healthcare system is that we don’t consider patients at the beginning of everything.” Mr. Simon’s advice for how to achieve greater patient centricity comes from his friend the professional cellist Yo-Yo Ma, who once suggested to him that “practice doesn’t make perfect; practice makes permanent.” Said another way, Mr. Simon argued that we’ve been practicing patient engagement in the wrong way and need to unlearn habits such as not considering patient quality of life in care decisions, or not involving patients in clinical trial design (a practice, we recently learned, that has massive potential for ROI). He closed this thought with another remark from Yo-Yo Ma regarding the constant effort that this kind of learning (or unlearning) requires – “amateurs practice until they get it right, but professionals practice until they cannot get it wrong.”
  • Mr. Simon illustrated the kind of culture change he’d like to see in the healthcare system with a nod toward his former work with the Obama administration’s Cancer Moonshot Initiative. The premise of the Moonshot was a challenge from President Obama to double the rate of progress in cancer care, to achieve in five years what would otherwise have taken ten. (Amazing, and wow would we love to see similar moonshot thinking in diabetes and prediabetes at the federal level.) As the Executive Director of the Cancer Moonshot Task Force, Mr. Simon brought together 20 government agencies – from expected players such as the NIH and Department of Health and Human Services to less conventional choices like NASA, the Department of Defense, and the National Endowment for the Arts – asking each to identify where it touches cancer patients on their journey from prevention to detection to diagnosis to treatment and finally to survivorship. He asked participants how their agency could double the impact of that touch now, by changing “business as usual.” Namely, he challenged each agency to collaborate with another agency in working toward this acceleration goal. A number of creative partnerships emerged, including the Department of Energy lending its supercomputers to the VA for data mining of medical records, the National Cancer Institute cooperating with NASA for radiation experiments, and the Department of Defense lending hundreds of thousands of blood samples (originally intended to test soldiers for HIV/AIDS) to NIH to create a “blood atlas” to identify biomarkers correlated with the progression to cancer later in life. We can only imagine the kinds of projects that could emerge if this level of effort was dedicated to diabetes and prediabetes – which affect far more people in the US than cancer and exact a far bigger toll on the US healthcare system.

The Crucial Role of Patient-Centered Research (PCR) in the Treatment of Type 1

Alicia McAuliffe-Forgarty, PhD (T1D Exchange, Boston, MA); Jeffrey Brewer (Bigfoot Biomedical, Milpitas, CA); Anne Kirstine Busk (Novo Nordisk, Copenhagen, Denmark); Magaly Perez-Nieves, PhD (Eli Lilly, Indianapolis, IN); Soren Skovlund, PhD (Aalborg University, Denmark)

Panelists and moderator Dr. Alicia McAuliffe-Forgarty (T1D Exchange, Boston, MA) discussed the broad potential applications of patient-centered research in type 1 diabetes. As Bigfoot’s Mr. Jeffrey Brewer put it, patient-reported outcomes (PROs) can be valuable for understanding differences between patients – a huge challenge in treating chronic disease, where treatment isn’t often individualized or risk-benefit decisions differ greatly. Different people value and prioritize different things, and that dynamic extends to health, so we need personalized solutions to meet the needs of all patients. Mr. Brewer pointed to differences between Dexcom and Abbott CGM to illustrate this concept: Does a patient want alarms or hate them? Does he/she want a constant influx of data? How about calibration? Success is determined first and foremost by whether a person uses a product, Mr. Brewer underscored, and this is where PROs are helpful – if not essential. Before PROs can be applied in regulatory settings, however, more work needs to be done to standardize the measures used in patient-centered research – an upcoming NIH/ADA meeting will discuss this in November. An international working group is currently designing a comprehensive set of valid PROs. It will also be important to connect with FDA and other players to create a universally-accepted research framework. From the audience, Mr. David Panzirer (Helmsley Charitable Trust) brought in the payer view: “The FDA is interested in PROs – the one thing missing is the payer perspective. How do PROs become important to payers? I think you have to prove them in studies and tie PROs to better outcomes that will save payers money. You’re spinning your wheels otherwise.” We completely agree and hope to see far more data-mining on this point – do PROs strongly correlate with short-term healthcare costs? If so, we’d guess these instruments would be fairly compelling to payers. See below for quotable quotes from this engaging session.

  • On engaging payers with PROs
    • I don’t think we ask payers enough why they don’t want to pay for things – it’s because people don’t use them in the real world. A study done at Stanford or Joslin doesn’t translate to the real world, and patients can’t make use of tools on a sustainable basis. We should ask for payer-reported outcomes – I’m serious.” – Mr. Jeffrey Brewer
    •  “It’s about presenting the data in a wise way. We’ll always have patients, payers, and providers with different ways of seeing the world, so it’s on us to make messages fit together to make it a win-win. – Ms. Anne Kirstine Busk
    •  “We just have to keep insisting that a good outcome in diabetes is not just A1c – it’s good control and good quality of life. Many clinics get people to good glycemic control but with depression and psychosocial issues.” – Dr. Soren Skovlund
  • On the need for standardized PROs
    • “We’re holding a conference next month (ADA/NIDDK Patient-Reported Outcomes in Diabetes) to accelerate the standardized use of validated PRO measures in diabetes research and practice and help identify what new measures need to be developed. Too many people implement generic quality of life meaures and then claim they don’t see a difference, but the truth is we don’t have a consensus on what diabetes specific measures  to use in clinical trials.” – Dr. Alicia McAuliffe-Fogarty
    • “What is the PRO corresponding to mySugr’s slogan, ‘make diabetes suck less’? What captures the subtlety of what that’s like? Once we get that going, we can connect evidence to value-based management to balance PROs and cost. It requires methodological and scientific diligence, and you have to be conscientious about the methods you use.” – Dr. Soren Skovlund
  • On applying patient-centered research
    • “If people aren’t using it, it should change. Apple doesn’t tell you to read the manual if you have a problem – they change the feature so it’s more intuitive.” – Mr. Jeffrey Brewer
    • “One of the problems in treating diabetes is that therapies aren’t designed for sustainable use from actual real-world users. Chronic disease offers this concept that you have to do something every day, all day, for the rest of your life. I can’t think of a single thing I’ve done that often except maybe drink coffee, but doing diabetes tasks gives you a message of failure and distracts you from what you care about. So, we should think about how to make therapies compatible with other priorities and fit into people’s lives. That perspective is really lacking right now, and it’s one we try to take at Bigfoot. It needs to be a qualitative thing that actually makes you feel better.” – Mr. Jeffrey Brewer
    • “If you take PRO research and focus on attributes of a product but don’t consider the broader context of family and care factors, you lose out on info about how technology interacts with surroundings…And also communication – what communication between a person with diabetes and caregivers is necessary to have the desired real-world effect?” – Dr. Soren Skovlund
    • “We need to use PROs intelligently to predict what happens in the real world. We have to make connections between what happens in clinical trials and what happens in the real world, then use that to inform future studies as well.” – Ms. Anne Kirstine Busk

The Diabetes Innovation Challenge

George Serbedzija, PhD (T1D Exchange, Boston, MA); Brent Buchine, PhD (Windgap Medical, Somerville, MA)

Dr. George Serbedzija shared an update on T1D Exchange’s Diabetes Innovation Challenge, which kicked-off last year as a new initiative attempting to accelerate innovation and explore solutions to needs in diabetes. From 57 applicants, 30 semifinalists were pared down to six winners, spanning pre-clinical and later-stage products. Projects included a very early stage low-cost implantable CGM (Integrated Medical Sensors), orally-administered intestinal coating for weight loss (Glyscend, mimics the benefits of bariatric surgery for people with type 2 diabetes), a glucagon autoinjector (WindGap Medical), an in-hospital artificial pancreas system (Admetsys), a low-cost retinopathy mask (Polyphotonix), and a non-radioactive autoantibody test (Enable Biosciences). See our coverage from last year here – it didn’t seem like these startups had made much progress over the past 12 months, though perhaps the coming year will see more.

T1D Exchange will launch the 2018 challenge this November (2017). The competition is open to all diabetes-related projects, and software developers, engineers, biomedical researchers, and healthcare workers are particularly encouraged to apply. T1D Exchange hopes to go even further back in the pipeline for this Challenge to focus more on early-stage innovation – we think that is a good choice, as the Exchange can help de-risk projects at an earlier stage and pave the way for subsequent fundraising through traditional channels. Applications will be reviewed from January through March 2018. Then, 10 finalists will receive coaching for a Boston-based pitch-off, where winners will be determined in May 2018. We’re glad to see this commitment to supporting entrepreneurs and hope to see a tangible victor(ies) emerge from this competition, similar to Locemia.

  • Dr. Brent Buchine, CEO of Windgap Medical and a 2016 winner, presented his company’s glucagon autoinjector. Windgap has attempted to make an easier glucagon injector using a rehydrating autoinjector: twisting the cap rehydrates the dose in two seconds, the product is temperature-stable, and the autoinjector container is smaller than today's standard glucagon kit. Since the autoinjector candidate uses the same doses as glucagon currently on the market, Windgap expects it won’t need to perform the same level of in-human clinical investigations, but only needs to show bioequivalence. Ambitiously, Dr. Buchine indicated that he expects ~3 more years of work to go into development and launch of this product. Given the number of companies in the glucagon competitive landscape, as well as the challenges for similar approaches like Enject, there is definitely a lot to prove here.

How Access Accelerates Scientific Advancement: The T1D Exchange Biobank

Wendy Wolf, PhD (T1D Exchange, Boston, MA); Peter Robinson, PhD (Enable Biosciences, San Francisco, CA)

Dr. Wendy Wolf overviewed the T1D Exchange Biobank, a repository of serum plasma, white blood cell, DNA, and RNA samples from >2,200 individuals with type 1 diabetes intended to accelerate the pace of research in this area. She described the philosophy of the Biobank as a place where scientists can access biological samples “from off the shelf,” saving time and reducing barriers to access. These samples come largely from past clinical trials in type 1 diabetes and are well-characterized. Dr. Wolf highlighted three ongoing studies of particular interest: (i) Dr. Chack-Yung Yu’s work on variation in immunity genes to identify people at risk for type 1 diabetes, (ii) Dr. Yuval Dor’s development of an assay for biomarkers to signify beta cell death, and (iii) Dr. Oibin Zhang’s work identifying protein biomarkers to predict the onset of diabetes complications.

  • On the subject of innovation in diabetes, Dr. Peter Robinson, CSO and co-founder of the San Francisco-based startup Enable Biosciences, described his company’s pioneering work in developing more sensitive and cost-effective type 1 diabetes antibody tests. Despite the benefits of antibody screening, Dr. Robinson pointed out that current radioimmunoassays are prohibitively expensive, a significant barrier for the screening of people with a family history of type 1 diabetes, let alone general population screening to identify the 80%-90% of people who will develop type 1 without a family history. Enable’s technology could potential remedy this issue, using an innovative approach called “antibody detection by agglutination-PCR” whereby antibodies are measured not by radioimmunoassay but by PCR, an easy and inexpensive genotyping technology that is virtually ubiquitous in laboratories and hospitals worldwide. In addition to being less expensive, this technique is between 100-1,000x more sensitive than traditional antibody measurement, suggesting that it could detect antibodies in saliva samples or in a single drop of dried blood, as opposed to the large blood samples required for radioimmunoassay. This would further increase the feasibility of large-scale screening by eliminating the need for blood draws and expensive blood sample refrigeration. We like the idea of economic, population-wide diabetes screening, and hope to see this move into later-stage clinical development.


-- by Ann Carracher, Abigail Dove, Payal Marathe, Adam Brown, and Kelly Close